BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791274 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14515
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) : THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED HIGH RESISTANCE/IMPEDANCE. THERE WAS 1 PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2012 21:00:10. THE DAILY PACE LEAD IMPEDANCE TREND DATA SHOWS A SPIKE INCREASE FOR VENTRICULAR PACE BI IMPEDANCE EQUAL TO 475 TO 4047 OHMS PEAK BETWEEN (B)(6) 2012, THEN RETURNING TO 475 OHMS ON (B)(6) 2012. INTERFERENCE/NOISE WAS ALSO NOTED. THE VENTRICULAR SHORT INTERVAL COUNT (V-SIC) WAS EQUAL TO 8797.7 COUNTS AVG/DAY, IN 1.72 DAYS, BETWEEN (B)(6) 2012 21:00:19 AND (B)(6) 2012 14:20:14. THERE WAS ALSO OVERSENSING. THERE WERE 10 VENTRICULAR NON-SUSTAINED TACHYCARDIA (NST) EPISODES LESS THAN OR EQUAL TO 210 MS ON (B)(6) 2012 IN THE TIMEFRAME BETWEEN 15:14:16 AND 16:10:23. THERE WERE 23 VENTRICULAR FIBRILLATION (VF) EPISODES LESS THAN OR EQUAL TO 210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2012 04:42:31 AND (B)(6) 2012 14:34:28. A LEAD INTEGRITY ALERT WAS TRIGGERED; THERE WERE 2 PATIENT ALERTS FOR LEAD FAILURE PREDICTOR ON (B)(6) 2012 20:04:44 AND (B)(6) 2012 12:47:54.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO "BAD SENSING VALUES" AND NOISE ON THE RIGHT VENTRICULAR LEAD. ANALYSIS OF PERFORMANCE DATA NOTED A PATIENT ALERT WAS TRIGGERED FOR HIGH IMPEDANCE AND OVERSENSING WAS OCCURRING. A HIGH NUMBER OF FAST SUPRA-VENTRICULAR TACHYCARDIA/NON-SUSTAINED TACHYCARDIA (SVT/NST) EPISODES OF SHORT DURATION WERE ALSO NOTED. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB